U.S. patent number 8,105,317 [Application Number 10/929,671] was granted by the patent office on 2012-01-31 for urethral sealing method and device.
This patent grant is currently assigned to Boston Scientific Scimed, Inc.. Invention is credited to Kenneth Reever, Jozef Slanda.
United States Patent |
8,105,317 |
Reever , et al. |
January 31, 2012 |
Urethral sealing method and device
Abstract
An urethral sealing device comprising first and second body
portions selectively attacheable to one another to form a unitary
element including a first catheter lumen extending therethrough
between proximal and distal ends of the unitary element wherein,
when the sealing device is in an operative position, the distal end
is positioned within a urinary bladder and a sealing element
extending radially outward from the unitary element so that, when
the sealing device is in the operative position, the sealing
element engages one of a wall of the urethra and a wall of the
urinary bladder around an orifice at which the urethra opens into
the urinary bladder to seal the urethra.
Inventors: |
Reever; Kenneth (Hopedale,
MA), Slanda; Jozef (Milford, MA) |
Assignee: |
Boston Scientific Scimed, Inc.
(Maple Grove, MN)
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Family
ID: |
35457086 |
Appl.
No.: |
10/929,671 |
Filed: |
August 30, 2004 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20060047269 A1 |
Mar 2, 2006 |
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Current U.S.
Class: |
604/544; 604/265;
604/266; 604/540 |
Current CPC
Class: |
A61M
25/0017 (20130101); A61M 27/008 (20130101); A61F
2/042 (20130101) |
Current International
Class: |
A61M
27/00 (20060101); A61M 1/00 (20060101); A61M
5/32 (20060101) |
Field of
Search: |
;600/29-32
;623/23.66,23.65,23.67,22.66 ;604/540,544,103.03 ;606/193 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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95/11637 |
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May 1995 |
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WO |
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03/094784 |
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Nov 2003 |
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WO |
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Other References
Answers.com, definition of "channel",
www.answers.com/topic/channel. cited by examiner.
|
Primary Examiner: Deak; Leslie
Assistant Examiner: Su; Susan
Attorney, Agent or Firm: Brown Rudnick LLP
Claims
What is claimed is:
1. A urethral sealing device comprising: first and second body
portions selectively attachable to one another to assume an
attached configuration forming a unitary element including a first
catheter lumen extending therethrough between proximal and distal
ends of the unitary element wherein, when the sealing device is in
an operative position, the distal end is positioned within a
urinary bladder and wherein, when in a detached configuration, a
first portion of a wall of the catheter lumen in the first body
portion is separated from a radially opposed second portion of the
wall of the catheter lumen in the second body portion; and a
sealing element extending radially outward from the unitary element
so that, when the sealing device is in the operative position, the
sealing element is adapted to engage one of a wall of the urethra
and a wall of the urinary bladder around an orifice at which the
urethra opens into the urinary bladder to seal the urethra, wherein
the unitary element further comprises a second catheter lumen
extending therethrough between the proximal and distal ends of the
unitary element, each one of the catheter lumen and the second
catheter lumen corresponding to a respective channel in a material
of the unitary element.
2. The urethral sealing device according to claim 1, further
comprising a fastening element for attaching the first and second
portions to one another.
3. The urethral sealing device according to claim 1, wherein the
first catheter lumen extends through the unitary element
substantially along a longitudinal axis thereof.
4. The urethral sealing device according to claim 1, wherein the
sealing element comprises a radially expandable portion expandable
to a radially enlarged configuration after insertion through the
urethra.
5. The urethral sealing device according to claim 1, wherein the
sealing element comprises a permanent flexible ridge adapted to
seat in the orifice at which the urethra opens into the urinary
bladder.
6. The urethral sealing device according to claim 1, wherein the
sealing element comprises an inflatable element disposed at a
distal end of the unitary element.
7. The urethral sealing device according to claim 6, wherein the
unitary element further comprises an inflation port fluidly
connected to the inflatable element.
8. The urethral sealing device according to claim 1, wherein the
unitary element further comprises a medication delivery port
fluidly connected to a medication delivery outlet at a distal end
of the unitary element.
9. The urethral sealing device according to claim 1, wherein the
first and second portions are formed of a semi rigid material.
10. The urethral sealing device according to claim 1, wherein the
sealing element is further adapted to mechanically retain the
unitary element in the urethra.
11. The urethral sealing device according to claim 9, wherein the
unitary element is formed of one of silicone, latex rubber,
ethylene vinyl acetate and polyethylene.
12. The urethral sealing device according to claim 1, wherein the
first and second body portions mate along an interface extending
substantially parallel to the first catheter lumen.
13. The urethral sealing device according to claim 12, wherein each
of the first and second body portions forms a part of a wall
defining the first catheter lumen.
14. The urethral sealing device according to claim 1, wherein the
first and second body portions are completely separable from one
another after being attached to one another.
15. A urethral sealing device comprising: first and second body
portions pivotally coupled to one another to form a unitary element
including a first catheter lumen extending therethrough between
proximal and distal ends of the unitary element wherein, when the
sealing device is in an operative position, the distal end is
positioned within a urinary bladder, the first and second body
portions being pivotable between an attached position in which
opposed faces of the first and second body portions mate with one
another and a separated position in which the first and second body
portions contact one another only at the pivotable coupling; and a
sealing element extending radially outward from the unitary element
so that, when the sealing device is in the operative position, the
sealing element is adapted to engage one of a wall of the urethra
and a wall of the urinary bladder around an orifice at which the
urethra opens into the urinary bladder to seal the urethra, wherein
the unitary element further comprises a second catheter lumen
extending therethrough between the proximal and distal ends of the
unitary element, each one of the first catheter lumen and the
second catheter lumen corresponding to a respective channel in a
material of the unitary element.
16. The urethral sealing device according to claim 15, wherein the
first and second body portions pivot relative to one another about
an axis substantially parallel to the first catheter lumen.
Description
BACKGROUND
Interstitial cystitis (IC) is a chronic inflammation or irritation
of the urinary bladder wall with symptoms including urinary
urgency, frequency, and often-severe pelvic and perineal pain which
are similar to those of other bladder diseases, such as urinary
tract infections (UTI), urethritis, urethral syndrome, trigonitis,
prostatitis, dysuria, and nocturia. Thus diagnosis of the IC is
difficult. After other similar bladder diseases have been ruled out
a cystoscopic examination of the bladder wall may be carried out.
If this examination reveals small petechial hemorrhages or larger
Hunner's Ulcers, IC is usually diagnosed.
The cause of IC remains undetermined. Theories linking IC to
bacterial infections are controversial as IC patients routinely
test negative for infection in standard urinalysis. However,
several studies have shown that symptoms are alleviated when IC
patients are treated with antibiotics. Other theories point to
defects in the epithelial permeability barrier of the bladder
surface glycosaminoglycans (GAG). Once the bladder wall has lost
the protective coating of GAG, irritative components and
potentially pathogenic bacteria may lead to the inflammation or
irritation associated with IC. Another line of research indicates
that activated mast cells associated with pain and irritation are
involved in the pathology of IC. Studies have shown that IC
patients have an increased level of activated mast cells in tissues
of their bladder walls.
Currently there is no treatment which permanently eliminates the
symptoms of IC in the majority of patients. Drug therapy has been
proven to be the most effective means of alleviating symptoms. Oral
medications for IC include bladder-coating agents, antidepressants,
antihistamines, antispasmodics and anesthetics. The effectiveness
of oral medications is limited by the circulating concentration of
the drug in the blood stream. To address this limitation, many IC
patients elect to undergo a procedure called urinary bladder
instillation, in which a therapeutic solution is pumped into the
bladder through a urethral catheter. The solution, which may be
composed of one medicine or a combination of medications, is held
in the bladder for a "dwell time" before the bladder is voided.
This procedure allows the treatment of the urinary bladder wall
directly with high concentrations of medicine. Despite the
drawbacks of a limited dwell time for the medication to take effect
and the resulting mixing of medication with urine, bladder
instillation remains among the most effective conventional
treatments for IC.
SUMMARY OF THE INVENTION
In one aspect, the present invention is directed to a urethral
sealing device comprising first and second body portions
selectively attacheable to one another to form a unitary element
including a first catheter lumen extending therethrough between
proximal and distal ends of the unitary element wherein, when the
sealing device is in an operative position, the distal end is
positioned within a urinary bladder and a sealing element extending
radially outward from the unitary element so that, when the sealing
device is in the operative position, the sealing element engages
one of a wall of the urethra and a wall of the urinary bladder
around an orifice at which the urethra opens into the urinary
bladder to seal the urethra.
The present invention is further directed to a system for treating
a urinary tract, comprising a bladder liner element which, when in
an operative position, is inserted in the bladder, an outflow
catheter extending from a proximal end of the bladder liner
wherein, when in the operative position, the outflow catheter
extends into the urethra, a first inflow catheter extending from a
distal end of the bladder liner wherein, when in the operative
position, the first inflow catheter extends into a first ureter and
a first ureter sealing element which, when the first inflow
catheter is in the operative position, prevents urine from flowing
into the bladder so that urine flows from the first inflow catheter
into the bladder liner and through the outflow catheter to pass out
of the body.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic drawing showing a bladder liner with three
openings designed to fit inside a patient's urinary bladder
according to an embodiment of the invention;
FIG. 2 is a schematic drawing showing of a bladder liner with three
catheters designed to fit inside a patient's urinary bladder
according to a second embodiment of the invention;
FIG. 3 is a schematic drawing showing a bladder liner with three
catheters designed to fit inside a patient's urinary bladder and
which includes a seal in the patient's urethra according to a third
embodiment of the invention;
FIG. 4 is a schematic drawing showing a bladder liner designed to
fit inside a patient's urinary bladder, having two catheters
insertable in the patient's ureters which expand to the diameter of
the ureter to form a fluid-impervious junction according to another
embodiment of the invention;
FIG. 5 is a schematic drawing showing a bladder liner designed to
fit inside a patient's urinary bladder, with two catheters which
extend to the patient's two kidneys according to a different
embodiment of the invention;
FIG. 6 is a schematic drawing of the bladder liner shown in FIG.
5;
FIG. 7 is a schematic drawing showing a bladder bypass designed to
fit inside a patient's urinary bladder, having two catheters
attached to the patient's two ureters and extending through the
urinary bladder and the urethra to an external urine container,
according to an embodiment of the invention;
FIG. 8 is a schematic drawing showing a bladder bypass designed to
fit inside a patient's urinary bladder, having two catheters
connected to the patient's ureters and joining to form one outlet
catheter, according to another embodiment of the invention;
FIG. 9 is a schematic drawing showing a bladder bypass designed to
fit inside a patient's urinary bladder, having two catheters
connected to the patient's ureters and each extending through a
suprapubic incision in the patient's abdominal wall, according to a
different embodiment of the invention;
FIG. 10 is a schematic drawing showing a bladder bypass designed to
fit inside a patient's urinary bladder, having two catheters which
join into one exit catheter extending through a suprapubic incision
in the patient's abdominal wall, according to the present
invention;
FIG. 11 is a schematic diagram showing a bladder bypass with an
urethral sealing glans according to an embodiment of the present
invention;
FIG. 12 is a perspective view of an urethral sealing glans in the
closed configuration, according to the present invention; and
FIG. 13 is a perspective view of the urethral sealing glans shown
in FIG. 12, in the open configuration.
DETAILED DESCRIPTION
The present invention provides a liner or bypass for the bladder,
so that urine is discharged without contacting the walls of the
bladder. The bypass or liner may be introduced through the urethra
and placed within the bladder. Various configurations of this
device will be described below, which are better suited for
different patients and applications.
In the course of treating the bladder with the liner according to
embodiments of the present invention, it may be necessary to
provide a fluid proof seal between the walls of the urethra and the
device, as well as between the walls of the two ureters and the
device. In particular, the openings of the ureters may be sealed to
prevent urine from entering the bladder and the urethra may be
sealed to retain medicated fluids introduced into the bladder
therein for a desired time. A sealing device may be used at the
opening of the bladder into the urethra to prevent such fluids from
leaking out prematurely.
FIG. 1 depicts an exemplary insert device 10 according to the
invention for isolating the wall 20 of the urinary bladder from
contact with urine. Urine normally flows from the kidneys into the
ureters 16A,B, which drain into the urinary bladder where it is
held until the urinary sphincter 26 relaxes. This allows urine to
flow from the bladder through the urethra 28 and out of the body.
The insert device 10 collects the urine entering the urinary
bladder via the ureters 16A,B and prevents contact between the
urine and the bladder wall 20. Isolating the bladder wall 20 from
the urine confers therapeutic benefits in the treatment of bladder
diseases, infections, and disorders. Specifically, isolating the
bladder wall 20 from urine allows medications introduced within a
space 22 between the bladder wall 20 and a liner 12 of the device
10 to function more effectively. It also allows the bladder wall 20
to be treated with medications introduced into the space 22 without
the medications being diluted by urine. Thus, the strength of the
medications is maintained and the medications are not flushed out
of the body too soon following the voiding of the bladder.
Urine is known to have a strong caustic effect on cells. In a
healthy bladder, specialized epithelial cells line the surface of
the wall 20 and are well adapted to survive the caustic environment
that urine creates. Isolating urine from the urinary bladder
provides a relatively non-caustic environment that allows
epithelial cells that have been damaged or which are in a diseased
state to better recover from disease or to fight infection. The
healing of the diseased inner wall of a patient's bladder is thus
greatly facilitated and expedited by use of the liner device
10.
In the exemplary embodiment of the invention shown in FIG. 1, a
liner 12 designed to fit inside the bladder is constructed, for
example, from an impermeable but highly flexible and elastic
material. The liner 12 forms a reservoir 13 in which urine is
collected. Materials suitable for the liner 12 include, for
example, vinyl, polyethylene, PVC, latex, silicone, ethylene vinyl
acetate, and polypropylene. The liner 12 is preferably constructed
with two inlet orifices 14A,B adapted to sealably connect to the
openings of the respective ureters 16A,B. The seals 18A,B between
the ureters 16A,B and inlet orifices 14A,B prevent urine from
leaking around the orifices 14A,B into the space 22 between the
wall 20 of the bladder and the liner 12.
The outlet orifice 24 of the liner 12 is adapted to extend into the
urethra 28, directing the flow of urine through the urethra 28 and
out of the body without contacting the surrounding tissue. The
outlet orifice 24 of this exemplary embodiment is shown extending
past the urinary sphincter 26. However, the outlet orifice 24 does
not have to extend past the urinary sphincter 26 so long as the
outlet orifice 24 is located in such a way as to prevent backflow
of urine into the bladder. The exemplary liner device 10 allows the
sphincter 26 to maintain normal function during the treatment,
which improves patient tolerance for the procedure.
Another exemplary embodiment of the invention is shown in FIG. 2.
In this embodiment, the liner device 10' comprises a liner 12
designed to fit inside the urinary bladder. The liner 12 is
preferably constructed from a substantially impermeable material,
as described above and includes a reservoir 13 formed therein. In
the device 10' of FIG. 2, each of two inlet orifices 14A,B is
connected directly to a respective one of two inlet catheters
27A,B. The inlet orifices 14A,B and the catheters 27A,B may be
joined by use of a fitting or any suitable bonding process known in
the art. In an operative position, the open ends of the two
catheters 27A,B are sealably connected to the openings of the
respective ureters 16A,B. As would be understood by those skilled
in the art, the sealing of the catheters 27A,B within the ureters
16A,B may be accomplished through mechanical means, such as with
the use of bio-adhesives, o-ring(s), or soft radial fins extending
from the catheters. The seals 18A,B may be disposed between the
ureters 16A,B and the corresponding input catheters 27A,B to
prevent urine from leaking into the space 22 and to ensure the flow
of urine into the liner 12. Suitable bioadhesives which may be
employed in the seals 18A,B and 31 (described below) include fibrin
glue, cynoacrylates, and collagen cuffs. Additional conventional
methods of sealing a catheter to a biological tissue may be
employed, as will be understood to those of skill in the art.
An outlet catheter 29 is connected to the outlet orifice 24 of the
bladder liner 12 and, in the operative position, extends through
the urethra 28 to direct the flow of urine through the urethra 28
and out of the body. In this exemplary embodiment, the outlet
catheter 29 extends into the urethra 28 beyond the location in the
urethra that is constricted by the urinary sphincter 26. The outlet
catheter 29 is preferably composed of a material sufficiently
flexible so that the catheter 29 can be completely compressed by
the urinary sphincter 26 to prevent incontinence and to improve
patient comfort.
An alternative embodiment of the liner device according to the
invention is shown in FIG. 3. Here, the outlet catheter 29 is
adapted to sealably connect to the wall of the urethra 28 above the
location in the urethra 28 that is constricted by the urinary
sphincter 26. The catheter 29 may be sealably connected to the
urethra using bioadhesives or one or more o-ring(s) 31 as described
above in regard to the seals 18A,B. In other embodiments, the seals
may comprise radial fins, balloons and/or collagen cuffs disposed
around the catheter 29 at an appropriate longitudinal position. As
discussed above, the connections between the ureters 16A,B and the
upper input catheters 27A,B are also sealable using seals 18A,B as
described above.
In several exemplary embodiments of the invention, the sealable
connections 18A,B and 31 may be formed by using at least one
nonpermanent biocompatible adhesive or sealant. In these
applications, the adhesive forms a fluid-impermeable seal that
prevents urine from passing through the annular space between the
catheters 27A,B and the ureter walls into the space 22 between the
wall 20 of the bladder and the liner 12. At the same time, the
seals 18A,B and 31 prevent medicated fluids introduced into the
space 22 from exiting the bladder.
In an alternative embodiment shown in FIG. 4, sealable connections
between the catheters 27A,B and the ureter walls are produced by
expanded diameter distal portions 33A,B of the catheters 27A,B
which press outward against the ureter walls to form a fluid tight
seal. The catheters 27A,B are held in place in the ureters 16A,B by
the mechanical force exerted by the expanded ends 33A,B of the
catheters on the surrounding biological tissues. Those skilled in
the art will recognize that a similar seal may be formed between
the catheter 29 and the wall of the urethra by inclusion of an
expanded diameter portion of the catheter 29 which, when in an
operative position, is located adjacent to a portion of the urethra
where a seal is desired. The exemplary connection used in the
insert device 10'' thus provides both a liquid-impermeable seal as
well as a mechanical connection which holds the catheters in place
within the patient's body.
An additional exemplary embodiment of the insert device according
to the present invention is shown in FIGS. 5 and 6. In this
embodiment, a liner device 10'''comprises a liner 12 made from an
impermeable but highly flexible and elastic material, designed to
fit inside the urinary bladder. The liner 12 includes a reservoir
13 formed therein and may include two catheters 35A,B connected to
inlet orifices 14A,B of the bladder liner 12. The catheters 35A,B
extend up the respective ureters 16A,B and into the kidneys 48.
FIG. 6 depicts distal portions of the catheters 35A,B which may,
for example, each of which comprises a coil 44 which prevents the
catheters 35A,B from migrating back down the ureters 16A,B towards
the bladder. In addition, the distal portions of each of the input
catheters 35A,B preferably posseses a plurality of drainage holes
42, so that the urine formed in the kidneys 48 can easily enter the
catheters 35A,B. Proximally of the drainage holes 42, the catheters
35A,B may be fitted with a plurality of fins 40 mounted on the
exterior surfaces of the catheters 35A,B which form
liquid-impermeable seals with the ureter walls. The fins 40 are
preferably constructed out of a soft, flexible material, allowing
them to be simply pushed against the ureter walls to form
liquid-impermeable seals. The liner 12 may also be constructed with
an outlet catheter 29 connected to an outlet orifice 24 of the
liner 12. The outlet catheter 29 may include any of the features of
the catheters 29 described above to direct the flow of urine
through the urethra 28 and out of the body.
In different embodiments according to the invention, the urinary
bladder liner 12 may be constructed of either a non-elastic
material or of a highly flexible and pliant material. However, it
may be necessary to wrap a non-elastic bladder liner around a
catheter 35A, B prior to insertion. A non-elastic bladder liner 12
will not expand to the dimensions of the urinary bladder, and thus
will not apply pressure to the urinary bladder wall 20 when the
bladder liner 12 is filled to or near to its capacity.
Alternatively, the liner 12 may be constructed of a highly
flexible, pliant material allowing the liner 12 to expand to the
dimensions of the urinary bladder. The preferred material to
construct the liner according to the invention may be selected
depending on the bladder condition to be treated, the condition of
the patient, and on the medical infrastructure available for the
procedure, among other variables.
The exterior surface of the urinary bladder liner 12 according to
the various embodiments presented herein may be coated with heparin
or a heparin-like drug to promote the healing of the bladder wall
20 at points where the bladder wall 20 and the bladder liner 12
make contact. In addition, the exterior surface of the urinary
bladder liner 12 may be coated with a low friction material such
as, for example, a hydrogel to reduce chafing or irritation of the
bladder wall 20 at points where the bladder wall 20 and the bladder
liner 12 make contact. These points may be subject to rubbing due
to movements of the patient over extended periods of time, and thus
require special handling to prevent complications from developing
as a result of the procedure. Known methods may be used to embed in
the outer surface of the bladder liner 12 the selected substances,
as a simple coating or a time release type of coating, depending on
the desired application.
Another embodiment of a device in accordance with the present
invention is shown in FIG. 7. In this case, the device forms a
bypass of the patient's bladder, so that the urine formed in the
kidneys does not dwell in the bladder, but rather is discharged out
of the patient's body through the bypass device 100. Two catheters
140A,B are inserted into the two openings of the ureters 106A,B in
the urinary bladder 112 and are sealably connected to the ureter
walls as described above in regard to the seals 18A,B. The two
catheters 140A,B extend through the urinary bladder 112 and through
the urethra 118 to exit the body. As would be understood by those
skilled in the art, the catheters 140A,B may lead to an external
collection container 144 of conventional design. A valve 142 on
each catheter 140A,B may be included to block the flow of urine
while removing or replacing the urine collection container 144.
Alternatively, a single valve 142 may be used to isolate the flow
of urine from each of the catheters 140A,B to the collection
container 144. The seals 108A,B used to seal the catheters 140A,B
to the ureter 106A,B may comprise bio-compatible adhesive(s),
o-ring(s) or fins, and alternatively may comprise portions of the
catheters that expand to press against the wall of the ureters
106A,B as described above.
A different embodiment represented by the bypass device 100' is
shown in FIG. 8. Two catheters 140A,B join in a Y connection to
form a third catheter 148 in the urinary bladder 112. The third
catheter 148 extends through the urethra 118 and into an external
collection container 144. As only the third catheter 148 passes
through the urethra 118 during normal functioning of the apparatus,
this design provides greater patient comfort. The third catheter
148 may be provided with a valve 142 disposed between the distal
end of the urethra 118 and the distal end of the catheter 148,
which functions to block the flow of urine while removing or
replacing the urine collection container 144. As would be
understood by those skilled in the art, the seals 108A,B used to
seal the catheters 140A,B to the ureters 106A,B may comprise
biocompatible adhesive(s), o-ring(s), or catheter end portions that
expand to press against the wall of the ureters 106A,B, as
described above. The catheters 140A,B and 148 may be joined at a
catheter junction 146 by use of a fitting or bonding, or may be
formed as a single assembly, according to conventional methods. The
exemplary catheters 140A,B 148 and catheter junction 146 may be
formed of materials comprising biocompatible plastics, such as
vinyl, polyethylene, PVC, silicone, ethylene vinyl acetate, and
polypropylene, among others.
In certain applications, the condition of the patient may make it
impractical to direct the outlet catheter(s) through the urinary
sphincter and out of the urethra. For those patients, irritation
and possible damage to the urethra and sphincter may require an
alternate routing for the drainage catheter. FIG. 9 shows an
additional exemplary embodiment of a bypass device 200 according to
the present invention. Here, each of the catheters 240A,B is
inserted into one of the ureters 206A,B and sealed to the ureter
walls, as described above. The two catheters 240A,B are extended
into the urinary bladder 212, through the bladder wall 210 out of
the body via incisions in the abdominal wall 250. Specifically, the
catheters 240A,B pass through one or more suprapubic incisions
252A,B surgically formed in the abdominal wall 250, for example,
superior to the patient's pubic arch.
This embodiment of a bladder bypass device according to the
invention eliminates urine drainage through the urethra 218,
thereby eliminating irritation of the urethra 218 and of the
urinary sphincter 216 due to the presence of the catheters 240A,B
passing therethrough. With no catheters 240A,B present in the
urethra 218, the urinary sphincter 216 is allowed to function
normally, thus providing greater comfort to the patient. Each one
of the catheters 240A,B leads into an external collection container
244A,B. A valve 242A,B may be provided on each catheter 240A,B to
block the flow of urine while removing or replacing the urine
collection container 244A,B. This may be done in a conventional
manner, as described above.
In an alternative embodiment, the catheters 240A,B may pass through
a single suprapubic incision 252 formed on one side of the
patient's abdomen, and may connect to a single external collection
container 244. In this exemplary embodiment, a single valve 242 may
be used to isolate the flow of urine from the catheters 240A,B to a
collection container 244. As described above, seals 208A,B may be
used to seal the gaps between catheters 240A,B and the ureters
206A,B. These seals 208A,B may comprise biocompatible adhesive(s),
o-ring(s), fins or distal portions of the catheters that expand to
press against the walls of the ureters 206A,B, as described
above.
A further embodiment of the device 200 is shown in FIG. 10. Two
catheters 240A,B join to form a third catheter 248 within the
urinary bladder 212. The third catheter 248 extends through the
patient's bladder wall 210 and through an incision 252 in the
abdominal wall 250 into an external collection container 244. This
embodiment also eliminates irritation of the urethra 218 and the
urinary sphincter 216, allows the urinary sphincter 216 to function
normally and increases patient comfort. The third catheter 248 may
include a valve 242 disposed between the incision 252 and the
distal end of the catheter 248 to block the flow of urine while
removing or replacing the urine collection container 244. The seals
208A,B used to seal the catheters 240A,B to the ureters 206A,B may
be formed of biocompatible adhesive(s), o-ring(s), or catheters
that expand to press against the wall of the ureters 206A,B, as
described above. According to this embodiment of the invention, The
catheters 240A,B and 248 may be joined at a catheter junction 246
by use of a fitting or bonding, or may be formed as a single
assembly according to conventional methods. The catheters 240A,B
248 and the catheter junction 246 may be formed of materials
comprising biocompatible plastics, such as vinyl, polyethylene,
PVC,-silicone, ethylene vinyl acetate, and polypropylene.
A more detailed view of a urethral sealing member used according to
embodiments of the present invention is shown in FIG. 11. In this
exemplary embodiment, each of a pair of catheters 300, 302 is
inserted through the bladder 22 into a respective one of the
ureters 16A,B. The two catheters 300, 302 are combined into a
single catheter 304 at a junction 308, so that only one catheter
exits the patient's body through urethra 28. In this manner, the
urethra 28 is kept open only as necessary to allow passage of one
catheter 304. It will be apparent to those of skill in the art that
the catheters 300, 302 may also remain separate, and pass through
urethra 28 independently. The outflow catheter 304 may be connected
at its proximal end to a urine storage/collection device 306, such
as a plastic bag or container.
As indicated above, it may be necessary in the course of
therapeutic procedures to introduce a medicated fluid into the
bladder 22 to topically treat the bladder wall 23. The function of
the catheters 300, 302 and of the catheter 304, if present, is to
prevent urine flowing from the ureters 16A, 16B from mixing with
medication infused into the bladder 22. A similar purpose is
carried out by the bladder liner elements described with respect to
other embodiments of the invention. In addition to preventing
dilution of the medication by the urine, the device according to
this embodiment retains the medication within the bladder 22 for a
specified dwell time selected to allow therapeutic agents in the
medication to act. The sphincter 26 alone may not be sufficient to
retain the medication for the desired dwell time since normal
voiding functions of the bladder may occur more frequently than the
required dwell time. A urethral sealing device may thus be used to
provide the desired dwell time, as well as to prevent any backflow
of urine into the bladder from the urethra.
An exemplary embodiment of such a urethral sealing device 310 is
shown in FIG. 11, to provide a fluid tight seal to the patient's
bladder 22. In this exemplary embodiment, the urethral sealing
device 310 is placed within the urethra 28 such that a body 314 of
the sealing device 310 extends substantially the length of the
urethra 28. A distal portion 312 of the body 314 forms a plug-like
sealing element which, after insertion of the sealing device 310
extends substantially within an orifice 308 to the urethra 28. A
proximal portion 316 of the body 314 may extend past the orifice
308 into the bladder 22 or may be somewhat shorter, depending on
the anatomy of the patient and the procedure being performed. In
the exemplary embodiment, the body 314 extends across the urinary
sphincter 26, from the bladder 22 to a proximal opening of the
urethra to an outside the of body.
The body 314 may have a multi-piece construction which allows
individual catheters to be placed independently within the bladder
22. For example, catheters 300, 302 may be placed within ureters
16A, 16B and may exit through the urethra 28 either separately or
joined into an outflow catheter 304. As described above, the seals
320 prevent urine from flowing therepast into the bladder 22. As
described above, the seals 320 may be blade-type or balloon seals,
for example. Once the appropriate catheters are in place, the body
314 of the sealing device 310 may be assembled around the catheters
and inserted into the urethra 28. Since the body 314 is
disassembled prior to insertion, it is not necessary to thread the
catheters into lumens of the urethral sealing device 310 as they
are inserted into the bladder 22. This method of assembly
simplifies the medical procedure, which can thus be carried out
more rapidly and with fewer personnel. The body 314 may be formed
of any soft, pliable, biocompatible material, such as, for example,
silicone, latex rubber, ethylene vinyl acetate or polyethylene.
An exemplary embodiment of the body 314 is shown in more detail in
FIGS. 12 and 13. The body 314 is formed of first and second
portions 330, 332 which are separable along a separation line 334.
The first and second portions 330, 332 may be separable completely,
or may pivot along a hinge line 336, so that the generally
cylindrical body 314 splits into two portions which are
substantially shaped like cylindrical half-shells when in the open
configuration. Fasteners 338 may be provided as needed to retain
the first and second portions 330, 332 together when the body 314
is in the closed configuration. The fasteners may be, for example,
friction fasteners, interlocking fasteners, or any other type of
fasteners known in the art.
Lumens are formed in the gland body 314 to let one or more outflow
catheters 304 pass through the urethral sealing device 310, and
extend from the bladder 22 to outside the patient's body. For
example, lumens 340 may be formed by the first and second portions
330, 332, so that catheters 300, 302 may pass therethrough. Lumens
340 may be formed substantially symmetrically by the first and
second portions 330, 332 or may, alternatively, be asymmetrical.
Additional lumens (omitted for clarity in FIG. 13) may be formed in
an analogous manner, and may be used for other purposes, such as
permitting passage of a drug delivery catheter 342 therethrough to
the bladder 22. The drug delivery catheter 342 may be used, for
example, to infuse the medicated solution(s) into the bladder 22
after the urethral sealing element 310 has been inserted.
A sealing element 350 may be provided at the distal end of body
314, to prevent fluid from escaping through the urethra 28, around
the body of the urethral sealing device 310. The sealing element
350 may comprise an enlarged portion 352 which acts as a plug in
the neck 308 of the bladder 22. For example, the enlarged portion
352 may be a permanent flexible ridge disposed at the distal end of
the body 314, which is adapted to seat in the urethral orifice 308
of the bladder 22. The flexible ridge of the enlarged portion 352
may comprise a gel or other suitable sealing structure. In an
alternative exemplary embodiment, the sealing element 350 may
comprise one or more inflatable elements, for example balloons 360,
which are inflated after the body 314 has been inserted into the
urethra 28 to improve the seal. The balloons 360 may be used alone
or together with the ridge of the enlarged portion 352, depending
on the application. An inflation port 362 connected to the
balloon(s) 360 and accessible from outside the patient's body
during the procedure, may also be provided. It will be apparent to
those of skill in the art that the urethral sealing device 310 may
be manufactured integrally with one or more of the catheters
300-304. In addition, a lubricious coating may cover all or
portions of the sealing device 310.
Methods to carry out medical procedures according to the invention
include treating bladder diseases by isolating urine from the
urinary wall through the use of the aforementioned bladder liner
and bladder bypass devices. Once the urine has been taken out of
contact with the bladder wall, the patient may be treated with
appropriate medications which may be applied topically directly to
the diseased bladder wall. No dilution of the medication or early
expulsion from the body occur according to the invention.
Appropriate medications that may be used include oral medications
comprising sodium pentosanpolysulfate, amitripyline, imipramine,
hydroxyzine dihydrochloride, hydroxyzine hydrochloride, hyoscyamine
sulfate, hyosyamine, oxybutynin chloride, flavoxate, urised, or
phenazopyridine hydrochloride. According to the invention,
appropriate medications which may be topically applied to the
bladder wall include DMSO, heparin, sodium oxychlorosene,
lidocaine, hydrocortisone sodium succinate, sodium bicarbonate,
capsaicin, hyaluronic acid, silver nitrate, or bacillus of Calmette
and Guerin (BCG). These medications may be instilled between the
bladder liner and bladder wall to achieve topical therapy to the
inner wall of the bladder. In the case of catheters used to bypass
the bladder, the medications may be instilled in the bladder, and a
urethral sealing device may be used in the urethra to retain the
medication in place for a specified period of time.
As described above, a urethral sealing device may be used at the
urethral orifice of the bladder. According to the exemplary
embodiment of the present invention shown in FIGS. 12 and 13, a
body 314 is separated into first and second components 330, 332
prior to insertion in the body. After one, two or more catheters
have been inserted into the bladder 22 (for example catheters 300,
302 and 304), the first and second portions 330, 332 are placed
around the catheters so that each catheter fits in a lumen 340
extending through the body 314. Alternatively, more than one
catheter may fit in each lumen, as long as a seal is maintained.
The first and second components 330, 332 are recombined and secured
into an unitary element, which may be inserted into the urethra 28.
A seal is then formed by a distal flexible ridge of the enlarged
portion 352 of the body 314 which may be augmenter or formed
separately by inflating balloons 360 through the inflation port
362.
Once the bladder liner/bypass device and the urethral sealing
device 310 are in place, a medicated fluid may be introduced into
the bladder 22, for example using an instillation port 342. After a
desired dwell time in the bladder 22, the medicated fluid may be
drained, and the urethral sealing device 310, together with the
catheters may be removed. The urethral sealing device 310 may be
removed following substantially the installation steps in reverse,
for example by separating the gland body 314 into first and second
components 330, 332. The exemplary embodiment of the invention may
be used in the treatment of, for example, interstitial cystitis,
bladder cancer, Hunner's ulcer, hemorrhagic cystitis, chronic
cystitis, recurrent cystitis, or other bladder condition.
The present invention has been described with reference to specific
exemplary embodiments. Those skilled in the art will understand
that changes may be made in details, particularly in matters of
shape, size, material and arrangement of parts. Accordingly,
various modifications and changes may be made to the embodiments.
The specifications and drawings are, therefore, to be regarded in
an illustrative rather than a restrictive sense.
* * * * *
References